EP3616617B1 - Lanzettenvorrichtung mit entfernung des ersten tropfs - Google Patents

Lanzettenvorrichtung mit entfernung des ersten tropfs Download PDF

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Publication number
EP3616617B1
EP3616617B1 EP19197197.7A EP19197197A EP3616617B1 EP 3616617 B1 EP3616617 B1 EP 3616617B1 EP 19197197 A EP19197197 A EP 19197197A EP 3616617 B1 EP3616617 B1 EP 3616617B1
Authority
EP
European Patent Office
Prior art keywords
lancet
housing
puncturing
lancet device
lancet structure
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP19197197.7A
Other languages
English (en)
French (fr)
Other versions
EP3616617A1 (de
EP3616617C0 (de
Inventor
Craig A. Gelfand
Gary D. Fletcher
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Becton Dickinson and Co filed Critical Becton Dickinson and Co
Priority to EP23180677.9A priority Critical patent/EP4233723A3/de
Publication of EP3616617A1 publication Critical patent/EP3616617A1/de
Application granted granted Critical
Publication of EP3616617C0 publication Critical patent/EP3616617C0/de
Publication of EP3616617B1 publication Critical patent/EP3616617B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150259—Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
    • A61B5/15045—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin comprising means for capillary action
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15109—Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15142—Devices intended for single use, i.e. disposable
    • A61B5/15144—Devices intended for single use, i.e. disposable comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Definitions

  • a lancet device in accordance with an embodiment of the present invention, includes a housing having a forward end and a rearward end; a lancet structure having a puncturing element, the lancet structure at least partially disposed within the housing and adapted for movement between a pre-actuated position wherein the puncturing element is retained within the housing and a puncturing position wherein at least a portion of the puncturing element extends through the forward end of the housing; and a wicking element disposed on a portion of the lancet structure.
  • the puncturing element pierces a portion of the wicking material during transition from the pre-actuated position to the puncturing position.
  • the lancet device further includes an actuation means for moving the wicking element to a position wherein the wicking element is capable of contacting a portion of a skin surface punctured by the puncturing element of the lancet structure.
  • a lancet device in accordance with another embodiment of the present invention, includes a housing having a forward end and a rearward end; a lancet structure having a puncturing element, the lancet structure at least partially disposed within the housing and adapted for movement between a pre-actuated position wherein the puncturing element is retained within the housing and a puncturing position wherein at least a portion of the puncturing element extends through the forward end of the housing; and a wicking element disposed on a portion of the housing.
  • the wicking element is disposed on a portion of the rearward end of the housing.
  • a portion of the rearward end of the housing defines a cavity and the wicking element is disposed within the cavity.
  • the housing includes a side surface between the forward end and the rearward end and the wicking element is disposed on a portion of the side surface of the housing.
  • the lancet device further includes a protective cover removably covering the puncturing element of the lancet structure.
  • the protective cover includes a post portion and the wicking element is disposed on a portion of the post portion of the protective cover.
  • the lancet device further includes an actuation member at least partially disposed within the housing, the actuation member sized for movement within a portion of the housing.
  • the actuation member includes a shield extending through the forward end of the housing and movable with respect to the housing, the shield including a shield forward end and a shield rearward end.
  • the wicking element is disposed on a portion of the shield forward end.
  • a lancet device in accordance with another embodiment of the present invention, includes a housing having a forward end and a rearward end; an actuation member at least partially disposed within the housing, the actuation member sized for movement within a portion of the housing, the actuation member including an actuation member forward end and an actuation member rearward end and defining a cavity between the actuation member forward end and the actuation member rearward end; a wicking element disposed within a portion of the cavity of the actuation member; and a lancet structure having a puncturing element, the lancet structure disposed at least partially within the housing and adapted for movement between a pre-actuated position wherein the puncturing element is retained within the housing and a puncturing position wherein at least a portion of the puncturing element extends through the forward end of the housing.
  • the retaining element includes a lever element pivotal about a fulcrum, the lever element providing interference engagement with the lancet structure and retaining the lancet structure in the pre-actuated position and adapted to retain the lancet structure against the bias of the drive spring, wherein movement of the actuation member toward the lever element causes a portion of the lever element to pivot about the fulcrum, thereby moving the lancet structure toward the rearward end of the housing to at least partially compress the drive spring and release the interference engagement between the lever element and the lancet structure, permitting the drive spring to drive the lancet structure through the housing toward the puncturing position.
  • the lancet device 10 generally includes a housing 12, a shield 14 movably associated with the housing 12, and a lancet structure 70 disposed therein.
  • the shield 14 is coaxially and movably associated with the housing 12, and is partially disposed within the housing 12, extending partially outward from the housing 12, with the lancet structure 70 contained within and axially or longitudinally movable through the shield 14.
  • main body 20 and rear cap 24 depict the main body 20 and rear cap 24, respectively, in an example of such an embodiment.
  • Main body 20 and rear cap 24 may be affixed together through an appropriate adhesive, or may include inter-engaging structure providing a mechanical attachment therebetween, such as a frictional fit or a snap fit construction.
  • main body 20 may include an annular rim 31 defining an annular groove 32
  • rear cap 24 may include an annular protrusion 33 having an annular lip 34 at mating surfaces thereof.
  • annular protrusion 33 extends within the rear open end of main body 20, with annular lip 34 snap fitting over the annular rim 31 and into the annular groove 32 of main body 20.
  • the generally elongated housing 12, defined by main body 20 and rear cap 24, has opposed sides 35, 36, which may each include a surface for accommodating a user's fingers, such as finger grip indentations 37, 38. While two opposed finger grip indentations 37, 38 are provided on the housing 12, it will be appreciated that only one finger grip indentation 37 formed in the housing body 20 may be provided in accordance with the present invention.
  • the finger grip indentations 37, 38 may be formed as concave depressions or recesses on the outer surface of the housing 12.
  • the rearward end 26 of housing 12, such as the top surface of rear cap 24, may also include a surface for accommodating a user's finger, such as rear finger grip indentation 39 as shown in FIGS.
  • the side finger grip indentations 37, 38 and the rear finger grip indentation 39 provide ergonomically shaped surfaces that substantially conform to a user's fingertips to aid the user in manipulating the lancet device 10 and using the lancet device 10 in a blood letting, drawing, or collection procedure, and may provide multiple finger grip positions for the user.
  • the side finger grip indentations 37, 38 may be represented as contours formed by a hyperbola as shown in FIG. 11B .
  • the hyperbola for example, may include two asymptotes that intersect at a location substantially coplanar with a plane of symmetry defining the main housing.
  • rear cap 24 may include a contour formed by a hyperbola, as shown in FIG. 11B .
  • the housing 12 may further include structure to generally improve the grip between the housing 12 and the user's fingertips, such as a plurality of longitudinal ribs 40 and troughs 41 extending along the housing 12 and integrally formed with the housing 12, which may provide a visual and tactile cue to the user to instruct the user where to place his or her fingertips.
  • the housing 12 may further include at least one and optionally two or more peripheral indentations 42 disposed at the forward end 22.
  • the lancet device may be constructed in accordance with the features disclosed in U.S. Patent Application Publication No. 2006/0052809 filed May 6, 2005 , and entitled "Contact Activated Lancet Device", and commonly assigned with the present application.
  • the shield 14 extends outward from the opening 30 through the forward end of the housing 12.
  • the shield 14 is a generally cylindrical hollow structure defining a shield body 50 extending between a forward end 52 and a rearward end 54, and defining an internal cavity 56 extending therethrough.
  • the forward end 52 of the shield body 50 defines a forward end wall 58 including a forward opening 60 therethrough, through which the puncturing element extends when the lancet device 10 is actuated by the user, as will be discussed in more detail herein.
  • the forward end wall 58 generally defines a small contact area about the distal opening 60 for contacting the intended area on the user's body which is to be punctured by the puncturing element.
  • the reduced contact area may be made smaller (i.e., reduced in area) by providing a plurality of peripheral indentations 62 that are formed in the shield 14.
  • the peripheral indentations 62 may also provide target indicia to visually aid the user in aiming the lancet device 10 generally, and aiming the puncturing element of the lancet in particular, as will be discussed in greater detail.
  • the peripheral indentations 62 generally resemble the peripheral indentations 42 provided on the housing 12.
  • the peripheral indentations 42 are positioned around the perimeter of the shield 14 and may be equally spaced about the shield 14. The peripheral indentations 42 enable the user to easily visually locate the approximate discharge point of the puncturing element, thereby improving the aiming characteristics of the lancet device 10 and ensuring optimal blood flow during a skin puncturing operation.
  • the shield 14 is axially or longitudinally movable within the housing 12.
  • the shield 14 and housing 12 may therefore include corresponding guiding surfaces for guiding the shield 14 through the housing 12.
  • shield body 50 may include a pair of longitudinal protrusions 63 extending along an outer surface thereof, forming guide channel 64 therebetween.
  • Housing 12 may include corresponding structure such as a guide tab 44 ( FIGS. 4B-4E ) within the main body 20 thereof for fitting within guide channel 64.
  • shield body 50 includes a pair of guide channels 64 extending longitudinally along opposing sides thereof, and housing 12 includes a pair of guide tabs 44 on opposing inner surfaces of main body 20 corresponding to each of the guide channels 64.
  • shield body 50 may include a ledge 66 at the rearward end thereof, for interference engagement with the top surface of guide tab 44 within main body 20 of housing 12.
  • shield body 50 may include a forward shoulder 69 toward the forward end thereof, and main body 20 of housing 12 may include a forward rim surface 48 ( FIGS. 4D-4E ), providing interference engagement therebetween.
  • Such interferingly engaging structure prevents shield body 50 from axially sliding completely out of housing 12 through opening 30.
  • the housing 12 and the shield 14 may further include locking structure extending therebetween, for maintaining the shield 14 in fixed relation to the housing 12 after activation.
  • shield body 50 may include structure at the rearward end 54 for frictional engagement, or for inter-fitting engagement, with the main body 20 or rear cap 24.
  • shield body 50 may include locking fingers 59 extending at the rearward end 54 thereof, for inter-fitting engagement with locking recesses 29 ( FIGS. 5A, 5B , and 5E ) within the interior surface of rear cap 24.
  • Puncturing end 74 is adapted for puncturing the skin of a patient, and may define a pointed end, a blade edge, and the like. Puncturing end 74 may include a preferred alignment orientation, such as with a pointed end of a blade aligned in a specific orientation.
  • shield body 50 and/or main body 20 of housing 12 may include target indicia corresponding to the alignment orientation of the puncturing end 74.
  • Indentations 62 of the shield body 50 and/or indentations 42 of the main body 20 may function as such an alignment orientation.
  • the guide tabs 78 and guide channels 80 ensure that the lancet structure 70 is properly aligned within shield body 50, and provide for sliding axial movement of the lancet structure 70 within the shield body 50 and may prevent or resist rotational movement.
  • a bottom surface 81 of the guide tabs 78 provides an abutment surface for abutting against a bottom surface of guide channels 80 to prevent the lancet structure 70 from axial movement entirely out of shield body 50 through forward opening 60.
  • a retaining hub 90 is further provided, shown at the rearward end 54 of the shield body 50.
  • Retaining hub 90 is desirably provided as a separate structure disposed or retained within the rearward end 54 of shield body 50.
  • shield body 50 may include structure for accommodating retaining hub 90, such as a recess 68 extending within an upper surface of rearward end 54. In this manner, retaining hub 90 rests within recess 68.
  • shield body 50 may include a surface for supporting and positioning retaining hub 90 to assist in assembly.
  • functional elements of the retaining hub 90 may be molded or formed directly onto the shield body 50.
  • the shield body 50 and lever element 92 may include inter-engaging structure to prevent lever element 92 from pivoting in a reverse direction about pivot hinge 98, regardless of the biasing force applied against lancet structure 70 and shoulder 94 through drive spring 102.
  • bottom angled surfaces 99 FIGS. 8C-8E ) formed from the wedge-shaped lever element 92 may engage and abut corresponding angled nubs 55 ( FIGS. 6D and 6F ) on the rearward end 54 of shield body 50.
  • Such inter-engaging surfaces prevent any applied force from drive spring 102 from pivoting the lever element 92 about pivot hinge 98 in a reverse direction, that is, in a direction such that shoulder 94 pivots downwardly into interior cavity 56 of shield body 50.
  • a retraction spring 110 may further be provided at the forward end of the lancet device 10, for retracting the lancet structure 70 within the shield body 50 after the lancet structure 70 is axially moved to the puncturing position.
  • Retraction spring 110 typically extends between a forward surface of the carrier element 76 of lancet structure 70 and an inner surface within the forward end wall 58 of the shield body 50.
  • Retraction spring 110 is typically a compression spring, capable of storing energy when in a compressed state.
  • lancet device 10 may further include a protective cover 120 for protectively covering the lancet device 10 prior to use thereof.
  • the protective cover 120 may include a tab member 122 associated with the forward end of the lancet device 10, which maintains sterility of the forward end wall 58 of shield body 50.
  • tab member 122 may include a forward tab portion 124 and a depending skirt 126.
  • the depending skirt 126 is adapted to cooperate with the forward end 52 of the shield body 50, generally encompassing or enclosing the forward end 52.
  • the depending skirt 126 also contacts the forward end 22 of the main body 20 of the housing 12.
  • the tab member 122 encloses forward opening 30 of main body 20 and forward opening 60 of shield body 50. Moreover, such arrangement maintains the respective forward ends of main body 20 and shield body 50 in fixed relation with respect to each other, thereby preventing movement therebetween which could cause premature activation of the lancet device 10.
  • the respective elements of the lancet device of the present invention are all typically formed of molded plastic material, such as a medical grade plastic material.
  • the lancet 72 may be constructed of any suitable material adapted for puncturing the skin, and is typically a surgical grade metal such as stainless steel.
  • lancet device 10 Prior to use, lancet device 10 is provided as shown in FIGS. 1 and 11D , with protective cover 120 covering shield 14 at the forward end thereof. Lancet device 10, and in particular lancet structure 70, is in an initial pre-actuation state, with finger 82 of carrier element 76 abutting or resting upon shoulder 94 of the lever element 92 in interference engagement therewith. In this manner, lever element 92 of the retaining hub 90 maintains lancet structure 70 in this pre-actuation position within housing 12, and in particular with puncturing end 74 maintained retracted within shield body 50.
  • the applied breaking force is in accordance with the present invention and may be a singular twisting or pulling motion, or a combined “twisting” (i.e., rotational) and “pulling” motion applied for breaking the connection between the post portion 130 and the carrier element 76, as well as to release the frictional engagement between the depending skirt 126 and the shield body 50.
  • the forward end wall 58 of shield body 50 may then be contacted with a location on the user's body or another person's body where it is desired to initiate blood flow, such as the patient's skin surface S as shown in FIG. 13 . If provided, target indicia, such as indentations 62, may be aligned with the desired location of puncture.
  • FIG. 19 depicts a cross-sectional view of a lancet device 10a in an alternate embodiment of the present invention.
  • actuation is achieved through an actuator including an actuation element, such as push button 25a.
  • a housing 12a is defined by a main body 20a and a rear cap 24a.
  • Push button 25a extends through housing 12a at rear cap 24a, and into an internal cavity 28a therein.
  • Actuation of lancet device 10a is accomplished by axially moving push button 25a within housing 12a, such that one or more engagement surfaces 47a at the forward end of push button 25a within housing 12a contact corresponding contact surface(s) 96a of a lever element 92a, thereby pivoting the lever element 92a about a pivot hinge 98a.
  • contacting and pivoting releases the interference engagement between a support surface 83a of a carrier element 76a and a shoulder 94a of lever element 92a, thereby permitting a drive spring 102a to propel a lancet 72a through housing 12a to the puncturing position.
  • the retraction spring 110 is a compression spring, and is therefore capable of being compressed in this manner, but includes sufficient resiliency to return to a relaxed condition after the lancet structure 70 extends to the puncturing position. Accordingly, the biasing force of the compression spring 110 between the forward end wall 58 of the shield body 50 and the lancet structure 70 when in a relaxed state exceeds the biasing force of the drive spring 102 acting between the rear cap 24 of the housing 12 and the rear nub 86 of the lancet structure 70 after the drive spring 102 drives the lancet structure 70 to the puncturing position.
  • the shield body 50 and the housing 12 may be locked in a fixed relation.
  • locking fingers 59 may deflect and lock within respective recesses 29, thereby locking shield body 50 in a rearward position with respect to rear cap 24 and housing 12.
  • the lancet device 10 is therefore safely protected from re-use and may be properly discarded, such as in an appropriate medical waste container.
  • the lancet device may include a modified version of a retaining hub 90i.
  • FIG. 20 shows the retaining hub 90i as part of the lancet device 10 as disclosed above, with similar reference numbers shown in FIGS. 20-22 referring to similar elements described in connection with FIGS. 1-18 .
  • Retaining hub 90i generally defines an annular shape and is adapted to maintain the lancet structure 70 in an initial armed position retracted within the housing defined by main body 20 and rear cap 24.
  • Retaining hub 90i typically includes two opposed and elongated support members 91i connected by two pivotal cam elements 92i to form the annular shape of retaining hub 90i.
  • Flexure members 238 are formed or provided on a proximal end 244 of the shield 213.
  • the flexure members 238 define structure for retaining the lancet structure in an initial armed position retracted within the housing, acting in a similar manner as the pivotal lever element and the retaining hub of the embodiments previously described in connection with FIGS. 1-18 .
  • projections 276 on the flexure members 238 extend inward so as to engage or coact with the carrier member 250 of the skin puncturing assembly 215.
  • the projections 276 engage or extend into a circumferential recess 210 defined or formed in the carrier member 250.
  • the recess 210 defines a circumferential edge 212, which is engaged by the projections 276 of the flexure members 238.
  • projections 276 tilt toward the rear end cap 240, thereby "lifting” or moving carrier member 250 toward rear cap 240 and compressing or further compressing drive spring 270.
  • the drive spring 270 is free to move the carrier member 250 from the retracted position to the puncturing position.
  • the drive spring 270 preferably has sufficient stored energy to cause the sharp distal tip 254 of the skin puncturing element 215 to pierce the skin of a person or animal once the flexure members 238 are released of engagement with the carrier member 250.
  • Actuation of the lancet device 10B is achieved in the same manner as described above.
  • lancet structure 70 is maintained in a pre-actuated position, i.e., the puncturing end 74 of lancet structure 70 is maintained retracted and shielded within shield body 50 and housing 12 as shown in FIG. 24 due to the interference engagement between finger 82 and shoulder 94.
  • the pivoting of lever elements 92 about pivot hinges 98 further displaces shoulders 94 toward the rearward end of rear cap 24, thereby further compressing and further biasing drive spring 102.
  • wicking material 300 is in contact with the portion of the skin S that is punctured by puncturing end 74 of lancet structure 70. In this manner, wicking material 300 automatically absorbs and wicks away the first drop of blood from the skin S of the patient.
  • lancet device 10B allows for wicking material 300 to automatically absorb and wick away the first drop of blood from the skin S of the patient without any additional steps and during normal operation of the lancet device 10B to puncture the skin S of the patient. In this manner, lancet device 10B of the present disclosure provides an efficient device that will help patients comply with the first-drop removal process to lead to more accurate blood test results.
  • FIGS. 26A , 26B , and 29A -30B illustrate another exemplary embodiment of a lancet device of the present disclosure.
  • This embodiment of the present disclosure similar to the embodiment illustrated in FIGS. 1-23D , is a lancet device 10C used in the medical field for puncturing the skin of a patient to obtain a blood sample from a patient.
  • Lancet device 10C includes a wicking material 300C as part of lancet device 10C to assist with the removal of a first-drop of blood to provide an efficient device that will help patients comply with the first-drop removal process to lead to more accurate blood test results.
  • the lancet device 10C illustrated in FIGS. 26A , 26B , and 29A -30B includes similar components to the lancet device 10 illustrated in FIGS.
  • lancet device 10C includes a recess or cavity 302 within a rear portion 331 of rear cap 24.
  • cavity 302 may contain a wicking material 300C.
  • FIG. 26A illustrates cavity 302 as a generally rectangular-shaped cavity, though it is contemplated that other shapes and sizes of cavity 302 may be used.
  • Cavity 302 may be any shape and size capable of storing a wicking material that is capable of absorbing the first amount of blood evolved from a lancet wound made upon activation of lancet structure 70.
  • the rear portion 331 of rear cap 24 may be formed of a wicking material 300C that is capable of absorbing the first amount of blood evolved from a lancet wound made upon activation of lancet structure 70.
  • cavity 302 may contain a wicking material 300C.
  • the wicking material 300C is made of a material that is capable of absorbing the first amount of blood evolved from a lancet wound made upon activation of lancet structure 70.
  • wicking material 300C may be formed of various absorbent materials such as cotton gauze, wicking paper, pressed paper materials, absorbent fibers, and various plastics having wicking properties. The important characteristics of the materials used to make wicking material 300C is that they are capable of absorbing the first amount of blood evolved from a lancet wound made upon activation of lancet structure 70.
  • a cap may be included over rear portion 331.
  • a wicking material may be disposed inside such a cap and could be exposed once the cap is removed. In this manner, the cap may help protect the wicking material during lancing.
  • the doors of the present disclosure illustrated in FIGS. 26B , 30A , and 32 may also help to protect the wicking material during lancing.
  • cavity 302 may include a door 304 that closes cavity 302 and may be used to seal wicking material 300C within cavity 302.
  • door 304 may be connected to rear portion 331 of rear cap 24 by a hinged portion 306. In this manner, door 304 may be transitioned between a closed position and an open position as shown in FIG. 26B .
  • door 304 may be made of a wicking material 300C that is capable of absorbing the first amount of blood evolved from a lancet wound made upon activation of lancet structure 70.
  • door 304 may be used as a sipper.
  • door 304 could be formed of a wicking material that could connect to an absorbent material behind it. In this manner, the sipper configuration could function like a straw that helps sip the blood. In other embodiments, a wicking material and lancet device of the present disclosure does not contain a door.
  • lancet device 10C having a rear portion 331 of rear cap 24 formed of a wicking material 300C that is capable of absorbing the first amount of blood evolved from a lancet wound made upon activation of lancet structure 70 will now be described.
  • Lancet structure 70 is maintained in a pre-actuated position, i.e., the puncturing end 74 of lancet structure 70 is maintained retracted and shielded within shield body 50 and housing 12 as shown in FIG. 24 due to the interference engagement between finger 82 and shoulder 94.
  • the pivoting of lever elements 92 about pivot hinges 98 further displaces shoulders 94 toward the rearward end of rear cap 24, thereby further compressing and further biasing drive spring 102.
  • lancet device 10C is turned upside down so that rear portion 331 of lancet device 10C is positioned in contact with the portion of the skin S that is punctured by puncturing end 74 of lancet structure 70.
  • lancet device 10C having a rear portion 331 of rear cap 24 formed of a wicking material 300C positioned in contact with the portion of the skin S that is punctured by puncturing end 74 of lancet structure 70 as shown in FIG.
  • lancet device 10C having wicking material 300C contained within cavity 302 at rear portion 331 of rear cap 24 to absorb a first amount of blood evolved from a lancet wound made upon activation of lancet structure 70 will now be described.
  • Lancet structure 70 is maintained in a pre-actuated position, i.e., the puncturing end 74 of lancet structure 70 is maintained retracted and shielded within shield body 50 and housing 12 as shown in FIG. 24 due to the interference engagement between finger 82 and shoulder 94.
  • the pivoting of lever elements 92 about pivot hinges 98 further displaces shoulders 94 toward the rearward end of rear cap 24, thereby further compressing and further biasing drive spring 102.
  • lancet device 10C of the present disclosure provides an efficient device that will help patients comply with the first-drop removal process to lead to more accurate blood test results.
  • wicking material 300C is available in a variety of shapes and sizes to be compatible with any lancet device for puncturing the skin of a patient to obtain a blood sample from a patient.
  • lancet device 10C is turned upside down so that door 304 at rear portion 331 of lancet device 10C is positioned in contact with the portion of the skin S that is punctured by puncturing end 74 of lancet structure 70.
  • first side cavity 310 may include a first door 314 that closes first side cavity 310 and may be used to seal wicking material 300D within first side cavity 310.
  • first door 314 may be connected to first side portion 332 of main body 20 by a first hinged portion 315. In this manner, first door 314 may be transitioned between a closed position and an open position.
  • first door 314 may be made of a wicking material 300D that is capable of absorbing the first amount of blood evolved from a lancet wound made upon activation of lancet structure 70.
  • door 314 may be used as a sipper.
  • door 316 could be formed of a wicking material that could connect to an absorbent material behind it. In this manner, the sipper configuration could function like a straw that helps sip the blood. In other embodiments, a wicking material and lancet device of the present disclosure does not contain a door.
  • FIG. 27 illustrates lancet device 10D having a first side cavity 310 within a first side portion 332 of main body 20 of housing 12 containing a wicking material 300D and a second side cavity 312 within a second side portion 334 of main body 20 of housing 12 containing a wicking material 300D
  • lancet device 10D may have a single side cavity containing a wicking material 300D.
  • lancet device 10D could have other numbers of cavities containing a wicking material to absorb a first amount of blood evolved from a lancet wound made upon activation of lancet structure 70.
  • lancet device 10E having post portion 130 of protective cover 120 formed of a wicking material 300E that is capable of absorbing the first amount of blood evolved from a lancet wound made upon activation of lancet structure 70 will now be described.
  • lancet device 10 prior to use, lancet device 10 is provided as shown in FIGS. 1 and 11D , with protective cover 120 covering shield 14 at the forward end thereof.
  • the user grasps housing 12, such as between a finger and thumb on opposing sides 35, 36, and removes the protective cover 120 from the forward end as shown in FIG. 2 , thereby exposing the shield body 50 extending from the forward end of main body 20 of housing 12.
  • FIGS. 33 and 34 illustrate another exemplary embodiment of a lancet device of the present disclosure.
  • This embodiment of the present disclosure similar to the embodiment illustrated in FIGS. 1-23D , is a lancet device 10F used in the medical field for puncturing the skin of a patient to obtain a blood sample from a patient.
  • Lancet device 10F includes a wicking material 300F as part of lancet device 10F to assist with the removal of a first drop of blood to provide an efficient device that will help patients comply with the first drop removal process to lead to more accurate blood test results.
  • the lancet device 10F illustrated in FIGS. 33 and 34 includes similar components to the lancet device 10 illustrated in FIGS.

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Claims (7)

  1. Lanzettenvorrichtung (10, 10a, 10E, 10F, 200) mit:
    einem Gehäuse (12, 12a, 211) mit einem vorderen Ende (22, 216) und einem hinteren Ende (26, 218);
    einer Lanzettenstruktur (70, 215) mit einer Antriebsfeder (102, 102a, 270), einer von der Antriebsfeder (102, 102a, 270) getrennten Rückzugsfeder (110, 274, 344), und einem Punktionselement (72, 72a), wobei die Lanzettenstruktur (70, 215) zumindest teilweise in dem Gehäuse (12, 12a, 211) angeordnet ist und zwischen einer vorbetätigten Position, in welcher das Punktionselement (72, 72a) in dem Gehäuse (12, 12a, 211) zurückgehalten ist, und einer Punktierposition bewegbar ist, in welcher zumindest ein Teil des Punktionselements (72, 72a) sich durch das vordere Ende (22, 216) des Gehäuses (12, 12a, 211) erstreckt;
    dadurch gekennzeichnet, dass die Lanzettenvorrichtung (10, 10a, 10E, 10F, 200) ferner aufweist:
    ein Betätigungselement (14), das zumindest teilweise in dem Gehäuse (12, 12a, 211) angeordnet ist, wobei das Betätigungselement (14) einen Schutzkörper (50) aufweist, der sich durch das vordere Ende (22, 216) des Gehäuses (12, 12a, 211) erstreckt und in Bezug auf das Gehäuse 12, 12a, 211) bewegbar ist, wobei der Schutzkörper (50) ein vorderes Schutzende (53) und ein hinteres Schutzende (54) aufweist, wobei das vordere Schutzende (52) eine vordere Endwand (58) mit einer Öffnung (60) aufweist; und
    ein Dochtelement (300, 300E, 300F), das an einem Bereich der Lanzettenvorrichtung (10, 10a, 10E, 10F, 200) angeordnet ist, wobei das Dochtelement (300, 300E, 300F) nahe dem vorderen Ende (22, 216) des Gehäuses (12, 12a, 211) angeordnet ist,
    wobei die Antriebsfeder (102, 102a, 270) dazu ausgebildet ist, in Reaktion auf das einwärts gerichtete Niederdrücken des vorderen Schützendes (52) zurück in Richtung des vorderen Endes (22, 216) des Gehäuses 12, 12a, 211), die Lanzettenstruktur (70, 215) von der vorbetätigten Position zu der Punktierposition zu treiben, und
    wobei die Rückzugsfeder (110, 274, 344) sich zwischen einer Vorderfläche eines Trägerelements (76) der Lanzettenstruktur (70, 215) und einer Innenfläche der vorderen Endwand (58) des Schutzkörpers (50) erstreckt und dazu ausgebildet ist, die Lanzettenstruktur (70, 215) von der Punktierposition in einer Rückstellrichtung in Richtung des Gehäuses (12, 12a, 211) zu bewegen.
  2. Lanzettenvorrichtung (10, 10a, 10E, 10F, 200) nach Anspruch 1, bei welcher das Gehäuse (12, 12a, 211) einen Hohlraum (28, 28a) definiert, und das Dochtelement (300, 300F) zumindest teilweise in dem Hohlraum (28, 28a) angeordnet ist.
  3. Lanzettenvorrichtung (10, 10a, 10F, 200) nach Anspruch 1, bei welcher das Punktierelement (72, 72a) einen Bereich des Dochtelements (300, 300F) während des Übergangs von der vorbetätigten Position zu der Punktierposition durchsticht.
  4. Lanzettenvorrichtung (10a, 10E, 200) nach Anspruch 1, ferner mit einer Schutzabdeckung (120, 282), die das Punktierelement (72, 72a) der Lanzettenstruktur (70, 215) lösbar abdeckt.
  5. Lanzettenvorrichtung (10E) nach Anspruch 4, bei welcher die Schutzabdeckung (120) einen Stiftbereich (130) aufweist, und das Dochtelement (300E) an einem Bereich des Pfostenbereichs (130) der Schutzabdeckung (120) angeordnet ist.
  6. Lanzettenvorrichtung (10F) nach Anspruch 1, ferner mit dem Dochtelement (300F), das vollständig in dem Gehäuse (12) der Lanzettenvorrichtung (10F) angeordnet ist, und
    einer Betätigungseinrichtung (342) zum Bewegen des Dochtelements (300F) zu einer Position, in welcher das Dochtelement (300F) in der Lage ist, einen Bereich einer Hautoberfläche (S) zu berühren, welcher durch das Punktierelement (72) der Lanzettenstruktur (70) punktiert wurde.
  7. Lanzettenvorrichtung (10F) nach Anspruch 6, bei welcher das Punktierelement (72) einen Bereich des Dochtelements (300F) während des Übergangs von der vorbetätigten Position zu der Punktierposition durchsticht.
EP19197197.7A 2014-07-18 2015-07-09 Lanzettenvorrichtung mit entfernung des ersten tropfs Active EP3616617B1 (de)

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PCT/US2015/039721 WO2016010817A1 (en) 2014-07-18 2015-07-09 Lancet device with first-drop removal

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CN106687040B (zh) 2020-06-09
EP3616617A1 (de) 2020-03-04
AU2018220064A1 (en) 2018-09-06
EP3598944B1 (de) 2021-03-03
ES2864412T3 (es) 2021-10-13
AU2018220062A1 (en) 2018-09-06
EP3616617C0 (de) 2023-08-30
AU2018220062B2 (en) 2019-12-19
JP6640830B2 (ja) 2020-02-05
CN106687040A (zh) 2017-05-17
WO2016010817A1 (en) 2016-01-21
AU2018220065A1 (en) 2018-09-13
US20170319120A1 (en) 2017-11-09
JP7189113B2 (ja) 2022-12-13
EP3598944A1 (de) 2020-01-29
AU2015290049A1 (en) 2017-02-09
AU2018220065B2 (en) 2019-12-19
JP2022028801A (ja) 2022-02-16
EP3169236A1 (de) 2017-05-24
CN111419247A (zh) 2020-07-17
AU2018220064B2 (en) 2019-12-19
AU2015290049B2 (en) 2018-09-06
EP4233723A2 (de) 2023-08-30
JP2020072911A (ja) 2020-05-14
EP3169236B1 (de) 2019-09-18
ES2761425T3 (es) 2020-05-19
EP4233723A3 (de) 2023-09-20
ES2954498T3 (es) 2023-11-22
US9743876B2 (en) 2017-08-29
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US10682085B2 (en) 2020-06-16
US20160015305A1 (en) 2016-01-21

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